Nobilis Influenza H5N6

RSS

adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Nobilis Influenza H5N6 has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 26/07/2010

Authorisation details

Product details
Name
Nobilis Influenza H5N6
Agency product number
EMEA/V/C/000125
Active substance
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84)
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
Species
Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI01AA23
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Intervet International BV
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
31/01/2008
Contact address
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

05/07/2010 Nobilis Influenza H5N6 - EMEA/V/C/000125 - S/0001

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

IMMUNOLOGICALS FOR AVES

Therapeutic indication

For active immunisation of chickens against avian influenza type A, subtype H5.
Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.
Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.

Assessment history

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